Attach 01 SON GE CardioLab Upgrade.docx

STATEMENT OF NEED (SON) FOR

DELIVERY, INSTALLATION, AND TRAINING OF CARDILAB UPGRADE AT

DEPARTMENT OF VETERANS AFFAIRS

CORPORAL MICHAEL J CRESCENZ VA MEDICAL CENTER

ATTN: MEDICINE SERVICE/ CARDIOLOGY DIVISON

3900 WOODLAND AVE

PHILADELPHIA, PA

19104-4551

1. GENERAL DESCRIPTION:

The Cardiac Catheterization Laboratory of Michael J Crescenz Medical Center is under the Cardiology Division of the Medicine Service line, directed by Dr. Andrew Epstein. The Cardiac Electrophysiology Physicians are licensed and credentialed to provide care to patients undergoing cardiac electrophysiology procedures that includes radiofrequency ablation, electrophysiology studies, permanent pacemaker/defibrillator placement, etc. The equipment specific to this request is called the Cardiolab System by GE Healthcare. The GE Cardiolab Altix BT21 System is used for diagnostic and therapeutic electrophysiology procedures for diagnosing and treating patients with aberrant heart rhythms that are too fast or too slow. The system, when connected to the patient, provides continuous monitoring, recording of invasive pressures, and a multi-channel, configurable waveform analysis that allows the operator to pinpoint the specific site of the rhythm abnormality, treat the aberrant rhythm and re-check the site of treatment to ensure the therapeutic intervention worked all while providing cardiac electrophysiologic recordings of finding and site-specific treatment for clinical documentation. It also comes with a hemodynamic package that allows the clinical team to provide continuous invasive and non-invasive monitoring during the procedure. This upgrade will enhance the operator’s ability to diagnose various cardiac arrhythmias, provide time-stamped procedural documentation and provide a full procedural record for transfer to the patient chart when completed. This upgrade is also necessary to bring the system to a supported Microsoft Windows platform.

2. SUPPLIES/SERVICES

Cardiolab System by GE Healthcare is for use in the cardiac electrophysiology laboratory during diagnostic and therapeutic electrophysiology procedures. The Cardiolab System by GE Healthcare is currently used in the Invasive Cardiac Labs. This request is for an upgrade to the latest software and hardware refresh and to bring the system to a Microsoft Supported Operating System and current technology. CMC VAMC respectfully requests that this system be procured via SDVOSB vehicle using TrillaMed. TrillaMed is SAM certified, verified by Vetbiz.gov. They work exclusively with GE Healthcare to provide goods and services to government healthcare entities. This request is for “Brand Name Only” GE CardioLab Altix BT21 System

3. SCHEDULE OF ITEMS

a. Item description of QTY/Unit/No. Supplies/Services

CVIS EP WF Only: This module is designed to allow for enhanced workflow within the department without the adoption of structured physician reporting. This module enables administrative workflow for electrophysiology related procedures in addition to list sharing management with GE CardioLab EP recording system.

MacLab/CardioLab PDF Results Integration; enables outbound distribution of clinical report from acquisition device to HIS/EMR in a .PDF format

TIP Invasive GEHC HQ Training Program; This training program is designed for customer representatives who have recently purchased GEHC Invasive equipment

INW Server PowerEdge R640 Server (210-AKWU) ProSupport Mission Critical: 4-Hour 7x24 On-Site Service with Emergency Dispatch, 3 Years (813-9259) ProSupport Mission Critical: 7x24 HW / SW Technical Support and Assistance, 3 Years (813-9265) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI)

(8) 8GB RDIMM, 3200MT/s, Single Rank (370-AEVO)

(2) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT)

(6) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT) Windows Server 2019 Standard,16CORE,FI,No Med, No CAL, Multi Language (634-BSFE)

(2) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT) (6)1.2TB 10K RPM SAS ISE 12Gbps 512n 2.5in Hot-plug Hard Drive (400-ASHI)

EA

CardioLab Production Server PowerEdge R740 Server (210-AKXJ) ProSupport Mission Critical: 4-Hour 7x24 On-Site Service with Emergency Dispatch, 3 Years (813-9123) ProSupport Mission Critical: 7x24 HW / SW Technical Support and Assistance, 3 Years (813-9129) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI)

(8) 8GB RDIMM, 3200MT/s, Single Rank (370-AEVO)

(2) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT)

(6) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT) Windows Server 2019 Standard,16CORE,FI,No Med, No CAL, Multi Language (634-BSFE)

EA

CardioLab Test Server PowerEdge R740 Server (210-AKXJ) ProSupport Mission Critical: 4-Hour 7x24 On-Site Service with Emergency Dispatch, 3 Years (813-9123) ProSupport Mission Critical: 7x24 HW / SW Technical Support and Assistance, 3 Years (813-9129) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI)

(8) 8GB RDIMM, 3200MT/s, Single Rank (370-AEVO)

(2) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT)

(6) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT) Windows Server 2019 Standard,16CORE,FI,No Med, No CAL, Multi Language (634-BSFE)

Integration

4. DELIVERY

a. Corporal Michael J. Crescenz Veterans Affairs Medical Center Philadelphia 3900 Woodland Avenue Philadelphia, PA 19104

60 Days from time of order. Anything other, please notify us.

5. SALIENT CHARACTERISTICS- Mac-Lab/CardioLab/ComboLab

· ComboLab- electrophysiology and hemodynamic functionality

· Interoperability between hemodynamic and electrophysiology functions

· HL7 data export

· INW (invasive networking) Server

· HD Video package with high-resolution pixel display, 24” widescreen monitors

· Invasive Networking: INW Server with DirectAssist applications

· ClearView technology to reduce eyestrain in darker work environments

· Color coded hotkeys, streamlined keyboard

· DirectConnect to connect existing IT and clinical infrastructure

· Clear, crisp electrophysiology signal processing to visualize small physiological signals throughout the procedure

· Multi-leg signal calipers to simplify complex interval measurement

· Windows 10 KSTB (64 -bit)

· Microsoft Office Professions Suite 2016

· INW Server SQL 2017

· CCW Server SQL 2016

· Workstation – Dell P5820 Acquisition System(s)

· Dell 5070 Review Workstation(s)

· 24” monitors

· PowerEdge R640 INW Server

· CLab II+ Amplifier- 128-channel

· Compatible with CARTO@ and Stockert Generator

· Compatible with Fischer Bloom 2 Stimulator

· SmartSignal- A learning filter that reduces powerline noise withle maintaining waveform morphology

· Moveable Phases

· ClearView user interface

· Streamlined macro window navigation

· HL7 Study Reports – created and exported in PDF format

· CLab II+ Amplifier following configurations:

· 128 channel amplifier

· Intracardiac Channels 108

· Stim 4

· Catheter inputs 224

· ECG 12 Lead

· Pressure 4 channel, range -25mmHg to 349

· Inputs compatible with 5uV/V/mm Hg pressure transducersechnical specifications (EP)

· ECG inputs

· High Pass Filter : 0.05Hz, 0.5Hz, 5.0Hz

· Low Pass Filter: 40Hz, 100Hz

· Gain: 50 – 10,000 in 8 settings Catheter/ Intracardiac

· High Pass Filter: DC, 0.05Hz, 0.5 Hz, 5.0 Hz, 30 Hz and 100 Hz

· Low Pass Filter: 150 Hz, 500 Hz, 1000 Hz

· Gain: 50 – 10,000 in 8 settings, Common Mode Rejection. Ratio (ECG and Intracardiac): 100dB min. Sampling Rate: 1K, 2K, 4K

6. STATEMENT OF WORK (SOW)

a. Project Scope The Corporal Michael J. Crescenz Veterans Affairs Medical Center (CMCVAMC) is looking to upgrade our existing electrophysiology monitoring/recording system to a Microsoft Security supported platform, with software and hardware enhancements to include the latest technology. The purchase must include end-user training for cardiology staff. All hardware, software components must be compatible with existing hardware/software Systems used in the Cardiac Electrophysiology Labs - Siemens ARTIS Q bi-plane, CARTO 3 Mapping System by Biosense Webster, Ensite Precision Mapping System by Abbott, SC2000 Intra-Cardiac Ultrasound .

b. Delivery Location CMCVAMC Philadelphia 3900 Woodland Avenue Philadelphia PA, 19104

c. Warranty and Support Warranty of the equipment must be provided for a minimum of one year upon receipt, acceptance of equipment. The warranty must cover all hardware and software components of the system. Warranty and support should include a 4-hour call back response during normal business hours of 7:30AM- 4:30 PM Monday thru Friday (except holidays). Any service reports sent to all appropriate points of contact. The vendor shall provide and install all manufacturer recommended software upgrades and changes included in the cost of the system during the warranty/contract period. The vendor shall provide two (2) sets of user manuals and technical manuals to VA Biomedical Engineering and site end user.

Repairs or services that are performed during normal working hours should be covered by warranty/contract.

d. Installation All work and installation shall be coordinated with the department Nurse Manager, site Biomedical Engineering team and the Contracting Officer Representative (COR) and a phasing and work-schedule shall be provided. All work is to be executed as to not interfere or interfere as little as possible with normal functions of the Medical Center and department. The contractor shall keep work, storage and staging areas clean and neat.

e. Testing The contractor shall verify to Biomedical Engineering and Cardiology Staff that the system meets all requirements through demonstration and validation. The contractor shall have no access to VA sensitive information during testing.

f. Training The contractor shall be responsible for providing on-site user training for the equipment. Each session of end-user training is to be scheduled at the CMC VAMC discretion and training shall have a one-year window.

g. Work Hours Normal business hours are 7:30 AM to 4:30 PM Monday thru Friday excluding Federal Holidays. Work completed outside this time must be requested through Facility Biomedical Engineering.

PERIOD OF PERFORMANCE Single procurement. No base or option period of performance.

MISCELLANEOUS INFORMATION: Payment Net 30 days.

POC INFORMATION: For any additional information contact Jill Neill, Nurse Manager Medicine- Cardiology, 215-823-5800 x203233 or Vera Taylor, Administrative Officer, Medicine Business office, 215-823-5800 x206317

VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS- 319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

4. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.